AB0627 Evaluation of internal consistency, feasibility, and reliability of the Italian version of ANCA-associated vasculitis patient-reported outcome (AAV-PRO_ita) questionnaire: preliminary results from a multicenter study on a large cohort of Italian patients
Authors: E. Treppo, M. Isola, M. De Martino, R. Padoan, M. L. Urban, S. Monti, S. Sartorelli, A. Giollo, L. M. Argolini, C. Marvisi, F. Ferro, G. Cassone, F. Motta, A. Berti, E. Conticini, A. Manfredi, B. Frediani, R. Bortolotti, C. Selmi, C. Baldini, G. Emmi, R. Caporali, M. Rossini, L. Dagna, C. Montecucco, F. Schiavon, C. Salvarani, S. De Vita, L. Quartuccio
Journal: Annals of the Rheumatic Diseases (2022)

Background The ANCA-associated vasculitis patient-reported outcome (AAV-PRO) questionnaire is a 29-item disease-specific PRO measure for AAV[1]. The Italian version of the AAV-PRO questionnaire (AAV-PRO_ita) was translated in collaboration with Oxford and Bristol University (UK) and was preliminarily tested on a single-center Italian cohort[2]. Objectives The main objective of this multicentric study was to assess the internal consistency, feasibility, and reliability of the AAV-PRO_ita in a large cohort of Italian AAV patients. The secondary objective was to investigate the clinical characteristics of AAV patients associated with AAV-PRO_ita domains. Methods The AAV-PRO_ita is describes the following disease domains: (1) organ-specific and systemic symptoms and signs (SSS); (2) physical function (PF); (3) social and emotional impact (SEI). In this study, Italian-speaking AAV patients were recruited from Italian Centres (N=13) with a large experience in the diagnosis and treatment of systemic vasculitis, belonging to the Vasculitis Study Group of the Italian Society of Rheumatology. Inclusion criteria were: a confirmed diagnosis of GPA, MPA, or EGPA; ANCA positivity in at least once occasion or biopsy-proven AAV; and age ≥18 years old. Participants completed the AAV-PRO_ita at three different time-points: baseline, after 5-7 days, and at month 3. Results 229 AAV-patients (56.3% women) with a median age of 61 (IQR 51-72) were recruited and completed the questionnaires. The subtype of AAV was mainly GPA (131, 57.2%), followed by EGPA (58, 25.3%), and MPA (40, 17.5%). Median BVASv3 at baseline was 0 (IQR 0-3), whereas the median BVASv3 at the onset of disease was 14 (IQR 9-20). Participants had a median duration of disease of 67 (IQR 24-126) months. Patients who experienced at least one relapse, one hospitalization, and one severe infection were 40.2%, 53.3%, and 24%, respectively. 83% of the patients were on immunosuppressant therapy and 71.6% were still receiving glucocorticoids (GC). AAV-PRO_ita questionnaire had good internal consistency (Cronbach’s Alpha range 0.81-0.93) and good test-retest reliability (ICCs range 0.93-0.96). Item response rates were high overall (maximum 0.87% missing data), supporting the feasibility of the questionnaire. Concerning the domains of the questionnaire, female AAV patients scored higher (i.e. worse) in all three domains, especially in the SEI domain (p-value&lt;0.001). Older participants (≥65 years) scored higher in the PF domain (p-value&lt;0.05) in all three times of self-completions of the questionnaire. The ongoing treatment also influenced the results. In fact, patients on GC showed higher scores in the PF domain (p-value=0.003) and SEI domain (p-value=0.021). The VDI value seemed to be related to AAV-PRO_ita scores more than disease duration or disease activity, especially in the SSS domain (ρ&gt;0.3, p-value&lt;0.001). Conversely, subtype of AAV did not influence the item scores. Conclusion The AAV-PRO_ita questionnaire is a new 29-item, disease-specific PRO measure for use in AAV in the Italian language. It is a self-administered Italian questionnaire with good internal consistency, feasibility, and reliability. AAV-PRO_ita proved to be a useful tool to explore the AAV patient’s perception of quality of life, and it could become an important way of measuring the unmet needs of AAV patients. References [1]Robson, J.C. et al. Validation of the ANCA-Associated Vasculitis Patient-Reported Outcomes (AAV-PRO) Questionnaire. Ann. Rheum. Dis. 2018 , 77 , 1157–1164, doi:10.1136/annrheumdis-2017-212713. [2]Treppo, E.; Palese, A.; Vita, S.D.; Quartuccio, L. AB0392 PRELIMINARY VALIDATION OF THE ITALIAN VERSION OF ANCA-ASSOCIATED VASCULITIS PATIENT-REPORTED OUTCOME (AAV-PRO_ita) QUESTIONNAIRE: FATIGUE AND CHRONIC PAIN AS UNMET NEEDS BY CURRENT TREATMENTS. Ann. Rheum. Dis. 2021 , 80 , 1224–1224, doi:10.1136/annrheumdis-2021-eular.2123. Acknowledgements We thank the Italian Study Group on Systemic Vasculitis. Disclosure of Interests None declared